Radionuclide Imaging (MIBG Scintigraphy)Phase 3NCT01336335
The Effects of Continuous Positive Airway Pressure (CPAP) on Sympathetic Activity in Different Sites of Activation
A Phase 3 study testing CPAP in people with Radionuclide Imaging (MIBG Scintigraphy) and Exercise Test, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Recent evidences suggest that obstructive sleep apnea (OSA) can contribute to cardiovascular disease even in the absence of hypertension. However, there are few data regarding the impact of OSA on the sympathetic system in apparently normotensive patients with OSA as well as the impact of treatment with continuous… Read more about this study
- Who is it for?
- Ages 30 to 60 years, men only
- Conditions the study is for
- Radionuclide Imaging (MIBG Scintigraphy), Exercise Test, Blood Pressure Monitoring, Ambulatory
- What is being tested?
- CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2010to Jul 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Severe OSA males
Who cannot join
- Smoking
- Sustained Hypertension
- Heart failure
- Diabetes
- Renal diseases
- Under use of any medication
- Under treatment for OSA
Trial locations and contacts
1 site in 1 country.
About this study
Recent evidences suggest that obstructive sleep apnea (OSA) can contribute to cardiovascular disease even in the absence of hypertension. However, there are few data regarding the impact of OSA on the sympathetic system in apparently normotensive patients with OSA as well as the impact of treatment with continuous positive airway pressure in different sites of activation (heart, peripheral nerves and circulating catecholamines)
- Conditions
- Radionuclide Imaging (MIBG Scintigraphy), Exercise Test, Blood Pressure Monitoring, Ambulatory, Sympathetic Nerve Activity, Catecholamines
- Being tested
- CPAP
- Keywords
- sleep apnea, obstructive, sympathetic nerve activity, treatment
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
CPAP
| Study group | Role | What they receive |
|---|---|---|
| CPAP | Experimental | OSA treatment with CPAP Receives: Device: CPAP |
| control | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement in sympathetic activity in muscle sympathetic nerve activity (MSNA)
Improvement in MSNA will be quantified as burst frequency over time (bursts per minute) and as burst frequency corrected for heart rate values (bursts per 100 heartbeats)in the begining and after 3 months.
Measured: 3 months
Secondary outcomes (1)
improvement in sympathetic activity evaluated in different sites of activation
All measurement will be performed at the begining and after 3 months. Blood: blood and 24 hour urine will be collected for norepinephrine quantification.
Heart: Early (15 min) and delayed (3 hr) planar images will be taken after injection of (123)I-MIBG. The mean counts of the whole heart and the mediastinum will be obtained to calculate heart-to-mediastinum count ratios from the early images (H/Me) and from the delayed images (H/Md) and the myocardial washout rate (WR).
Blood pressure: 24 hour ambulatory blood pressure monitoring and blood pressure during exercise test (treadmill test)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2011 (estimated)
- Study startJul 2010
- Primary completionJul 2011 (estimated)
- Study completionJul 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radionuclide Imaging (MIBG Scintigraphy)Studies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Rodrigo Pedrosa, MD, PhD, Principal investigator, Heart Institute (InCor)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01336335
- Sponsor's protocol ID
- Sympathetic activity and OSA
- Status last verified
- Jul 2010
- First submitted
- 13 Apr 2011
- Last updated
- 15 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Continuous Positive Airway Pressure (CPAP) on Sympathetic Activity in Different Sites of Activation
- ClinicalTrials.gov ID
- NCT01336335
- Acronym / sponsor ID
- Sympathetic activity and OSA
- Conditions
- Radionuclide Imaging (MIBG Scintigraphy), Exercise Test, Blood Pressure Monitoring, Ambulatory, Sympathetic Nerve Activity, Catecholamines
- Keywords
- sleep apnea, obstructive, sympathetic nerve activity, treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Jul 2011 (estimated)
- First posted
- 15 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recent evidences suggest that obstructive sleep apnea (OSA) can contribute to cardiovascular disease even in the absence of hypertension. However, there are few data regarding the impact of OSA on the sympathetic system in apparently normotensive patients with OSA as well as the impact of treatment with continuous positive airway pressure in different sites of activation (heart, peripheral nerves and circulating catecholamines)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP | Experimental | Device: CPAPOSA treatment with CPAP |
| control | No intervention | –no intervention |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Severe OSA males
Key exclusion criteria (7 listed)
- Smoking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAPCPAP | Device | CPAP |
Primary outcome
improvement in sympathetic activity in muscle sympathetic nerve activity (MSNA)
Time frame: 3 months
Improvement in MSNA will be quantified as burst frequency over time (bursts per minute) and as burst frequency corrected for heart rate values (bursts per 100 heartbeats)in the begining and after 3 months.
1 secondary outcome
improvement in sympathetic activity evaluated in different sites of activation
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodrigo Pedrosa, MD, PhD principal investigator
Heart Institute (InCor)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CPAP in people with Radionuclide Imaging (MIBG Scintigraphy) and Exercise Test, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement in sympathetic activity in muscle sympathetic nerve activity (MSNA) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2011.